(151 days)
This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Iconic Nitrile Glove - Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Large.
The provided text describes the acceptance criteria and the results of a study for the "Iconic Nitrile Glove," a non-powdered patient examination glove.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristics/Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Average Results) | Final Status |
|---|---|---|---|---|
| Freedom from hole - ASTM D5151-19 | Freedom from hole | AQL 2.5 | Non sterile (for all sizes: Small, Medium, Large, X-Large) | Pass |
| Dimensions | Overall Length (mm) | Min 230mm | Small: 234.9, Medium: 246, Large: 236.5, X-Large: 241.0 | Pass |
| Dimensions | Width (±10mm) | Small - 80, Medium- 95, Large-110, X-large-120 | Small: 84.7, Medium: 97.4, Large: 106.4, X-Large: 114.6 | Pass |
| Dimensions | Thickness at Palm | Min: 0.05 mm | Small: 0.10, Medium: 0.06, Large: 0.08, X-Large: 0.09 | Pass |
| Dimensions | Thickness at Fingertip | Min: 0.05 mm | Small: 0.12, Medium: 0.10, Large: 0.13, X-Large: 0.13 | Pass |
| ASTM D6319-19 (Before Aging) | Physical properties before aging - Tensile Strength | 14 MPa, min. | Small: 21.2, Medium: 25, Large: 18.9, X-Large: 18.4 | Pass |
| ASTM D6319-19 (Before Aging) | Physical properties before aging - Ultimate Elongation | 500 % min | Small: 896.3, Medium: 893.8, Large: 919.7, X-Large: 930.9 | Pass |
| ASTM D6319-19 (After Accelerated Aging) | Physical properties after accelerated aging - Tensile Strength | 14 MPa, min. | Small: 23.5, Medium: 26.8, Large: 22.2, X-Large: 19.3 | Pass |
| ASTM D6319-19 (After Accelerated Aging) | Physical properties after accelerated aging - Ultimate Elongation | 400 % min | Small: 879.2, Medium: 787.9, Large: 855.3, X-Large: 858.6 | Pass |
| Powder-free Residue - ASTM D6124-06 | Powder-free Residue | < 2.0 mg per glove | Small: 0.78, Medium: 0.24, Large: 0.38, X-Large: 0.54 | Pass |
| ISO 10993-5 | Test for Invitro cytotoxicity | Cytotoxic Characteristics (Pass) | Pass | Pass |
| ISO 10993-10 | Test for irritation and Skin Sensitization | Non - Skin Sensitized (Pass) | Pass | Pass |
| ISO 10993-11 | Tests for systemic toxicity | Not induce systemic toxicity (Pass) | Pass | Pass |
| ISO 10993-23 | Tests for irritation | Non-Irritant (Pass) | Pass | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for each test (e.g., how many gloves were tested for pinholes, or how many samples for biocompatibility). However, it refers to standard methodologies like ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, and ISO 10993 series, which inherently define sample sizes for achieving statistical significance. The data provenance is not specified beyond the fact that the tests were conducted for "Iconic Medicare Sdn Bhd" located in Malaysia. It is a non-clinical, laboratory-based testing scenario.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For this type of device (nitrile gloves), the ground truth is established through adherence to standardized international test methods (ASTM and ISO standards) and their specific acceptance criteria, rather than expert consensus on subjective observations.
4. Adjudication method for the test set
Not applicable. As the ground truth is based on quantitative measurements and adherence to specified standard criteria, no human adjudication method (like 2+1 or 3+1) is mentioned or implied.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a nitrile glove, not an AI-powered diagnostic or assistance tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a nitrile glove, not an algorithm.
7. The type of ground truth used
The ground truth is established by adherence to internationally recognized standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124-06, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-23) which define specific physical, mechanical, and biological properties and their acceptance limits.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 11, 2021
Iconic Medicare Sdn Bhd % A.C. Thirumaran Official Correspondent Integrated Assessment Services Pvt Ltd 1495, Manasarovar, 16th Main Road, Anna Nagar West Chennai, Tamil Nadu 600040 India
Re: K212182
Trade/Device Name: Iconic Nitrile Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: October 26, 2021 Received: November 10, 2021
Dear A.C. Thirumaran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence W. Murray, III, PhD. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K212182
Device Name Iconic Nitrile Glove
Indications for Use (Describe)
This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Iconic Medicare Sdn Bhd 510(k) Premarket submission Iconic Nitrile Glove
510(K) Summary K212182
ICONIC NITRILE GLOVE
Preparation Date: 12/10/2021
1. Submitter:
Mr. Tan Cho Chia Managing Director Company Name: Iconic Medicare Sdn Bhd. Company Address: No. 1-2,jalan City, Icon City.14000, Bukit Mertajam, Pulau Pinang, Malaysia Telephone No: 6045040588 Email: cctan(@jconic.com.my
2. Name of the Device
Trade Name / Proprietary Name: Iconic Nitrile Glove Device Common Name: Powder Free Nitrile Examination gloves. Device Classification Name: Polymer Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA
3. Official Correspondent
Mr.A.C.Thirumaran Integrated Assessment Services Private Limited No.1495, Manasarovar, 16th Main road, Anna Nagar west, Chennai- 600040, India. Email: iasfda16@gmail.com
4. Identification of the Legally Marketed Device:
Predicate Device: Meditech Gloves SDN BHD 510k Number: - K210755 Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Device Classification Name: Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA
{4}------------------------------------------------
5. Device Description
The subject device in this 510(k) Notification is Iconic Nitrile Glove - Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Large.
6. Intended use of the Device
Iconic Nitrile Glove, a polymer patient examination glove is a disposable device & Non Sterile which is intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. It is for over-the-counter use.
{5}------------------------------------------------
| /. Technological characteristics Comparison for the proposed and predicatedences | |||||
|---|---|---|---|---|---|
| CharacteristicsAcceptance Criteria | Subject device:Iconic Nitrile Glove- Blue | Predicate Device | Remarks | ||
| (Small, Medium, Large,X-Large) | Powder Free Nitrile PatientExamination Gloves, Non-Sterile (Blue) | ||||
| Product Code | LZA | LZA | LZA | same | |
| Intended use | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner. Thedevice is for over- the-counter use. | This powder free patientexamination glove is adisposable device intendedfor medical purposes thatis worn on the examiner'shand to preventcontamination betweenpatient and examiner. Thedevice is for over- the-counter use. | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contaminationbetween patient andexaminer. | same | |
| Material used | Nitrile compound | Nitrile compound | Nitrile compound | same | |
| Colour | N/A | Blue | Blue | same | |
| Sterility | Sterile/Non-sterile | Non sterile | Non sterile | same | |
| Single use | Single use | Single use | Single use | same | |
| Dimensions | Overall Length (mm) Min Meets ASTM D6319-19230mm | Meets ASTM D6319- 19 | same | ||
| Width (±10mm)Small - 80Medium- 95Large-110X-large-120Thickness at Palm (mm) | Meets ASTM D6319- 19Meets ASTM D6319- 19 | Meets ASTM D6319- 190.06— 0.09mm | |||
| Min; 0.05 mmThickness at Finger Tip | Meets ASTM D6319- 19 | 0.07-0.10mm | |||
| (mm) Min 0.05 mm | |||||
| PhysicalProperties | a.Before Aging(i) Tensile Strength=14 MPa,min.(ii) Ultimate Elongation= 500 %min | Meets ASTM D6319- 19 | Meets ASTM D6319- 19 | same |
7. Technological characteristics Comparison for the proposed and predicatedevices
{6}------------------------------------------------
lconic Medicare Sdn Bhd
510(k) Premarket submission
Iconic Nitrile Glove
| b. After Accelerated Aging(i) Tensile Strength=14 MPa,min.(ii)Ultimate Elongation= 400 %min | ||
|---|---|---|
{7}------------------------------------------------
Iconic Medicare Sdn Bhd 510(k) Premarket submission
Iconic Nitrile Glove
| Freedom frompinholes | AQL 2.5Inspection Level G-1 | Meets ASTM D5151- 19 | Meets ASTM D5151- 19 | same |
|---|---|---|---|---|
| ResidualPowder | < 2.0 mg/pc | Meets ASTM D6124- 06Result obtained: 0.24 | Meets ASTM D6124- 06 | same |
| ISO 10993-10:2010Biological evaluation ofmedical devices — Part10: Tests for irritationand skin sensitization | Under the conditions of thisstudy, the test article was anon- irritant. | Under the conditions of thisstudy, the test article was anon- irritant. | same | |
| Biocompatibility | ISO 10993-10:2010Biological evaluation ofmedical devices — Part10: Tests for irritationand skin sensitization | Under the conditions of thisstudy, the test article was anon- sensitizer. | Under the conditions of thisstudy, the test article was anon- sensitizer. | same |
| ISO 10993-5:2009Biological evaluation ofmedical devices - Part5: Tests for in vitrocytotoxicity | Complies with therequirement of thisstandard | Complies with therequirement of this standard | Same | |
| ISO 10993-11:2017Biological evaluation ofmedical devices — Part11: Tests for systemictoxicity | Not induce systemictoxicity | N/A | same |
{8}------------------------------------------------
8. Summary of non-clinical testing results
Iconic Nitrile Glove was tested and found in conformance with the following standards:
| ASTM D6319-19 | Standard Specification for Nitrile Examination Gloves for Medical Application |
|---|---|
| ASTM D5151-19 | Standard Test Method for detection of Holes in Medical Gloves |
| ASTM D6124-06 | Standard Test Method for Residual Powder on Medical Gloves |
| ISO 10993-5 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation on medical device Part 10: Test for irritation and SkinSensitization |
| ISO 10993-11 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity |
| ISO 10993-23 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| TestMethodology | Purpose | AcceptanceCriteria | Average Results | Finalstatus | |||
|---|---|---|---|---|---|---|---|
| Sterility | SMALL | Medium | Large | X Large | - | ||
| Freedom fromhole - ASTMD5151-19 | AQL 2.5 | Non sterile | Non sterile | Non sterile | Non sterile | Pass | |
| Dimensions -width, Length,Thickness | Overall Length(mm) Min230mm. | 234.9 | 246 | 236.5 | 241.0 | Pass | |
| Width (±10mm)Small - 80Medium- 95Large-110X-large-120 | 84.7 | 97.4 | 106.4 | 114.6 | Pass | ||
| Thickness at Palm & fingertip Min: 0.05 mm | |||||||
| Palm | 0.10 | 0.06 | 0.08 | 0.09 | Pass | ||
| Fingertip | 0.12 | 0.10 | 0.13 | 0.13 | Pass | ||
| a. Before Aging | |||||||
| ASTM D6319-19 | Physicalproperties beforeaging, afteraccelerated aging | TensileStrength=14 MPa,min. | 21.2 | 25 | 18.9 | 18.4 | Pass |
| UltimateElongation= 500% min | 896.3 | 893.8 | 919.7 | 930.9 | Pass | ||
| b. After Accelerated Aging | |||||||
| TensileStrength=14 MPa,min. | 23.5 | 26.8 | 22.2 | 19.3 | Pass | ||
| UltimateElongation= 400% min | 879.2 | 787.9 | 855.3 | 858.6 | Pass | ||
| Powder-freeResidue exceedsmaximum limit -ASTM D6124-06 | < 2.0 mg perglove | 0.78 | 0.24 | 0.38 | 0.54 | Pass | |
| ISO 10993-5 | Test for Invitrocytotoxicity | CytotoxicCharacteristics | Pass | ||||
| ISO 10993-10 | Test for irritationand SkinSensitization | Non - SkinSensitized | Pass |
{9}------------------------------------------------
| ISO 10993-11 | Tests for systemictoxicity | Not inducesystemic toxicity | Pass |
|---|---|---|---|
| ISO 10993-23 | Tests for irritation | Non-Irritant | Pass |
9. Summary of clinical Performance data
Not applicable - Clinical data was not used to assess performance of the subject device.
10. Conclusion
The Conclusion drawn from the Non-Clinical test demonstrates that the subject device- Iconic Nitrile Glove is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K210755.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.